Status:
COMPLETED
Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly
Lead Sponsor:
Federico II University
Collaborating Sponsors:
University of Genova
Conditions:
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formu...
Detailed Description
This is an open, prospective, observational, clinical study to be performed in two University Hospitals (Naples and Genova, Italy). The primary objective is to evaluate the efficacy of the ATG 120 mg ...
Eligibility Criteria
Inclusion
- Patients with active acromegaly \[serum GH levels above 2.5 μg/liter and/or above 1 μg/liter after oral glucose tolerance test (OGTT) and abnormal IGF-I values\] with a micro- (\<10 mm max tumor diameter) or macroadenoma (\>10 mm max tumor diameter)
- Patients never treated before
- Patients who do not require immediate surgery because of neurological symptoms and/or emergency conditions
- Patients who signed an informed consent to participate to the study.
Exclusion
- Patients already treated before with surgery or radiotherapy or with medical treatment
- Patients with mixed GH-PRL adenomas who require combined somatostatin and dopamine treatment
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00627796
Start Date
January 1 2003
End Date
December 1 2007
Last Update
March 3 2008
Active Locations (1)
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1
Annamaria Colao
Naples, Italy, 80131